Trans-oral circular anvil introduction system with dilation feature

ABSTRACT

An anvil introduction system is operable to provide smooth insertion of an anvil of a surgical stapling device through a bodily lumen such as the esophagus. The anvil introduction system is coupled to the anvil and includes a dilation feature. The dilation feature has a collapsed position and an expanded position. The dilation feature may cover staple pockets and an outer edge of the anvil with the dilation feature is in the expanded position. The anvil may be inserted through the bodily lumen with the dilation feature in the expanded position. The dilation feature may then be collapsed in order to complete an end-to-end anastomosis of the bodily lumen.

BACKGROUND

In some settings, a surgeon may want to position a surgical instrumentthrough an orifice of the patient and use the instrument to adjust,position, attach, and/or otherwise interact with tissue within thepatient. For instance, in some surgical procedures, portions of thegastrointestinal tract may be cut and removed to eliminate undesirabletissue or for other reasons. Once the desired tissue is removed, theremaining portions may need to be recoupled together. One such tool foraccomplishing these anastomotic procedures is a circular stapler that isinserted through a patient's orifice.

Examples of circular surgical staplers are described in U.S. Pat. No.5,205,459, entitled “Surgical Anastomosis Stapling Instrument,” issuedApr. 27, 1993; U.S. Pat. No. 5,271,544, entitled “Surgical AnastomosisStapling Instrument,” issued Dec. 21, 1993; U.S. Pat. No. 5,275,322,entitled “Surgical Anastomosis Stapling Instrument,” issued Jan. 4,1994; U.S. Pat. No. 5,285,945, entitled “Surgical Anastomosis StaplingInstrument,” issued Feb. 15, 1994; U.S. Pat. No. 5,292,053, entitled“Surgical Anastomosis Stapling Instrument,” issued Mar. 8, 1994; U.S.Pat. No. 5,333,773, entitled “Surgical Anastomosis Stapling Instrument,”issued Aug. 2, 1994; U.S. Pat. No. 5,350,104, entitled “SurgicalAnastomosis Stapling Instrument,” issued Sep. 27, 1994; and U.S. Pat.No. 5,533,661, entitled “Surgical Anastomosis Stapling Instrument,”issued Jul. 9, 1996. The disclosure of each of the above-cited U.S.patents is incorporated by reference herein. Some such staplers areoperable to clamp down on layers of tissue, cut through the clampedlayers of tissue, and drive staples through the layers of tissue tosubstantially seal the severed layers of tissue together near thesevered ends of the tissue layers, thereby joining two severed ends ofan anatomical lumen.

Merely additional other exemplary surgical staplers are disclosed inU.S. Pat. No. 4,805,823, entitled “Pocket Configuration for InternalOrgan Staplers,” issued Feb. 21, 1989; U.S. Pat. No. 5,415,334, entitled“Surgical Stapler and Staple Cartridge,” issued May 16, 1995; U.S. Pat.No. 5,465,895, entitled “Surgical Stapler Instrument,” issued Nov. 14,1995; U.S. Pat. No. 5,597,107, entitled “Surgical Stapler Instrument,”issued Jan. 28, 1997; U.S. Pat. No. 5,632,432, entitled “SurgicalInstrument,” issued May 27, 1997; U.S. Pat. No. 5,673,840, entitled“Surgical Instrument,” issued Oct. 7, 1997; U.S. Pat. No. 5,704,534,entitled “Articulation Assembly for Surgical Instruments,” issued Jan.6, 1998; U.S. Pat. No. 5,814,055, entitled “Surgical ClampingMechanism,” issued Sep. 29, 1998; U.S. Pat. No. 6,978,921, entitled“Surgical Stapling Instrument Incorporating an E-Beam Firing Mechanism,”issued Dec. 27, 2005; U.S. Pat. No. 7,000,818, entitled “SurgicalStapling Instrument Having Separate Distinct Closing and FiringSystems,” issued Feb. 21, 2006; U.S. Pat. No. 7,143,923, entitled“Surgical Stapling Instrument Having a Firing Lockout for an UnclosedAnvil,” issued Dec. 5, 2006; U.S. Pat. No. 7,303,108, entitled “SurgicalStapling Instrument Incorporating a Multi-Stroke Firing Mechanism with aFlexible Rack,” issued Dec. 4, 2007; U.S. Pat. No. 7,367,485, entitled“Surgical Stapling Instrument Incorporating a Multistroke FiringMechanism Having a Rotary Transmission,” issued May 6, 2008; U.S. Pat.No. 7,380,695, entitled “Surgical Stapling Instrument Having a SingleLockout Mechanism for Prevention of Firing,” issued Jun. 3, 2008; U.S.Pat. No. 7,380,696, entitled “Articulating Surgical Stapling InstrumentIncorporating a Two-Piece E-Beam Firing Mechanism,” issued Jun. 3, 2008;U.S. Pat. No. 7,404,508, entitled “Surgical Stapling and CuttingDevice,” issued Jul. 29, 2008; U.S. Pat. No. 7,434,715, entitled“Surgical Stapling Instrument Having Multistroke Firing with OpeningLockout,” issued Oct. 14, 2008; and U.S. Pat. No. 7,721,930, entitled“Disposable Cartridge with Adhesive for Use with a Stapling Device,”issued May 25, 2010. The disclosure of each of the above-cited U.S.patents is incorporated by reference herein. While the surgical staplersreferred to above are described as being used in endoscopic procedures,it should be understood that such surgical staplers may also be used inopen procedures and/or other non-endoscopic procedures.

While various kinds of surgical stapling instruments and associatedcomponents have been made and used, it is believed that no one prior tothe inventor(s) has made or used the invention described in the appendedclaims.

BRIEF DESCRIPTION OF THE DRAWINGS

While the specification concludes with claims which particularly pointout and distinctly claim this technology, it is believed this technologywill be better understood from the following description of certainexamples taken in conjunction with the accompanying drawings, in whichlike reference numerals identify the same elements and in which:

FIG. 1 depicts a side elevation view of an exemplary circular staplingsurgical instrument;

FIG. 2A depicts an enlarged longitudinal cross-section view of anexemplary stapling head assembly of the instrument of FIG. 1 showing anexemplary anvil in an open position;

FIG. 2B depicts an enlarged longitudinal cross-sectional view of thestapling head assembly of FIG. 2A showing the anvil in a closedposition;

FIG. 2C depicts an enlarged longitudinal cross-sectional view of thestapling head assembly of FIG. 2A showing an exemplary staple driver andblade in a fired position;

FIG. 3 depicts an enlarged partial cross-sectional view of an exemplarystaple formed against the anvil;

FIG. 4A depicts an enlarged side elevation view of an exemplary actuatorhandle assembly of the surgical instrument of FIG. 1 with a portion ofthe body removed, showing a trigger in an unfired position and a lockoutfeature in a locked position;

FIG. 4B depicts an enlarged side elevation view of the actuator handleassembly of FIG. 4A, showing the trigger in a fired position and thelockout feature in an unlocked position;

FIG. 5 depicts an enlarged partial perspective view of an exemplaryindicator assembly of the surgical instrument of FIG. 1 showing anindicator window and indicator lever;

FIG. 6 depicts an diagrammatic view of the indicator window of FIG. 5showing an exemplary indicator bar and exemplary corresponding staplerepresentations;

FIG. 7 depicts a schematic view of an exemplary circular stapler systembeing used in an esophagectomy procedure;

FIG. 8 depicts an enlarged partial perspective view of an exemplarytrans-oral circular anvil introduction system showing a dilation featurein a deflated state;

FIG. 9A depicts a cross sectional view of the anvil introduction systemof FIG. 7 showing the dilation feature in the deflated state;

FIG. 9B depicts a cross sectional view of the anvil introduction systemof FIG. 7 showing the dilation feature in an inflated state;

FIG. 10 depicts an enlarged partial perspective view of the anvilintroduction system of FIG. 7 showing the dilation feature in theinflated state passing through a lumen;

FIG. 11 depicts an enlarged partial perspective view of anotherexemplary trans-oral circular anvil introduction system showing adilation feature in an expanded state;

FIG. 12 depicts a cross sectional view of the anvil introduction systemof FIG. 11 taken along the line 12-12 of FIG. 11;

FIG. 13 depicts an enlarged partial perspective view of the anvilintroduction system of FIG. 11 showing the dilation feature in theexpanded state with a mesh covering;

FIG. 14 depicts a cross sectional view of the anvil introduction systemof FIG. 13;

FIG. 15 depicts an enlarged partial perspective view of the anvilintroduction system of FIG. 11 showing the dilation feature in acollapsed state with a mesh covering;

FIG. 16 depicts a cross sectional view of the anvil introduction systemof FIG. 15;

FIG. 17A depicts an enlarged partial perspective view of the anvilintroduction system of FIG. 11 passing through a lumen;

FIG. 17B depicts an enlarged partial perspective view of the anvilintroduction system of FIG. 11, showing the anvil introduction systemremoved from the anvil;

FIG. 18 depicts an enlarged bottom perspective view of an exemplaryanvil with a grasping feature;

FIG. 19A depicts an enlarged partial perspective view of the anvil ofFIG. 18, showing the anvil in an introduction position within a lumen;

FIG. 19B depicts an enlarged partial perspective view of the anvil ofFIG. 18, showing rotation of the anvil within the lumen;

FIG. 19C depicts an enlarged partial perspective view of the anvil ofFIG. 18, showing the anvil approaching a stapling position within thelumen;

FIG. 20 depicts an enlarged top perspective view of another exemplaryanvil with a grasping feature;

FIG. 21A depicts a cross sectional view of the anvil of FIG. 20, showingan anvil locking feature in a collapsed state;

FIG. 21B depicts a cross sectional view of the anvil of FIG. 20, showingthe anvil locking feature in an expanded state;

FIG. 22A depicts an enlarged partial perspective view of an exemplaryanvil securing feature within a lumen, showing the lumen being suturedin a purse-string configuration; and

FIG. 22B depicts an enlarged partial perspective view of the anvilsecuring feature of FIG. 22A showing the lumen in a cinched position andsecured to the anvil by the suture.

The drawings are not intended to be limiting in any way, and it iscontemplated that various embodiments of the technology may be carriedout in a variety of other ways, including those not necessarily depictedin the drawings. The accompanying drawings incorporated in and forming apart of the specification illustrate several aspects of the presenttechnology, and together with the description serve to explain theprinciples of the technology; it being understood, however, that thistechnology is not limited to the precise arrangements shown.

DETAILED DESCRIPTION

The following description of certain examples of the technology shouldnot be used to limit its scope. Other examples, features, aspects,embodiments, and advantages of the technology will become apparent tothose skilled in the art from the following description, which is by wayof illustration, one of the best modes contemplated for carrying out thetechnology. As will be realized, the technology described herein iscapable of other different and obvious aspects, all without departingfrom the technology. Accordingly, the drawings and descriptions shouldbe regarded as illustrative in nature and not restrictive.

I. Overview of Exemplary Circular Stapling Surgical Instrument

FIGS. 1-6 depict an exemplary circular surgical stapling instrument (10)having a stapling head assembly (20), a shaft assembly (60), and anactuator handle assembly (70), each of which will be described in moredetail below. Shaft assembly (60) extends distally from actuator handleassembly (70) and stapling head assembly (20) is coupled to a distal endof shaft assembly (60). In brief, actuator handle assembly (70) isoperable to actuate a staple driver (24) of stapling head assembly (20)to drive a plurality of staples (66) out of stapling head assembly (20).Staples (66) are bent to form completed staples by an anvil (40) that isattached at the distal end of instrument (10). Accordingly, tissue (2),shown in FIGS. 2A-2C, may be stapled utilizing instrument (10).

In the present example, instrument (10) comprises a closure system and afiring system. The closure system comprises a trocar (38), a trocaractuator (39), and a rotating knob (98). An anvil (40) may be coupled toa distal end of trocar (38). Rotating knob (98) is operable tolongitudinally translate trocar (38) relative to stapling head assembly(20), thereby translating anvil (40) when anvil (40) is coupled totrocar (38), to clamp tissue between anvil (40) and stapling headassembly (20). The firing system comprises a trigger (74), a triggeractuation assembly (84), a driver actuator (64), and a staple driver(24). Staple driver (24) includes a knife (36) configured to severtissue when staple driver (24) is actuated longitudinally. In addition,staples (66) are positioned distal to a plurality of staple drivingmembers (30) of staple driver (24) such that staple driver (24) alsodrives staples (66) distally when staple driver (24) is actuatedlongitudinally. Thus, when trigger (74) is actuated and triggeractuation assembly (84) actuates staple driver (24) via driver actuator(64), knife (36) and members (30) substantially simultaneously severtissue (2) and drive staples (66) distally relative to stapling headassembly (20) into tissue. The components and functionalities of theclosure system and firing system will now be described in greaterdetail.

A. Exemplary Anvil

As shown in FIGS. 1-2C, anvil (40) is selectively coupleable toinstrument (10) to provide a surface against which staples (66) may bebent to staple material contained between stapling head assembly (20)and anvil (40). Anvil (40) of the present example is selectivelycoupleable to a trocar or pointed rod (38) that extends distallyrelative to stapling head assembly (20). Referring to FIGS. 2A-2C, anvil(40) is selectively coupleable via the coupling of a proximal shaft (42)of anvil (40) to a distal tip of trocar (38). Anvil (40) comprises agenerally circular anvil head (48) and a proximal shaft (42) extendingproximally from anvil head (48). In the example shown, proximal shaft(42) comprises a tubular member (44) having resiliently biased retainingclips (46) to selectively couple anvil (40) to trocar (38), though thisis merely optional, and it should be understood that other retentionfeatures for coupling anvil (40) to trocar (38) may be used as well. Forexample, C-clips, clamps, threading, pins, adhesives, etc. may beemployed to couple anvil (40) to trocar (38). In addition, while anvil(40) is described as selectively coupleable to trocar (38), in someversions proximal shaft (42) may include a one-way coupling feature suchthat anvil (40) cannot be removed from trocar (38) once anvil (40) isattached. Merely exemplary one-way features include barbs, one waysnaps, collets, collars, tabs, bands, etc. Of course still otherconfigurations for coupling anvil (40) to trocar (38) will be apparentto one of ordinary skill in the art in view of the teachings herein. Forinstance, trocar (38) may instead be a hollow shaft and proximal shaft(42) may comprise a sharpened rod that is insertable into the hollowshaft.

Anvil head (48) of the present example comprises a plurality of stapleforming pockets (52) formed in a proximal face (50) of anvil head (48).Accordingly, when anvil (40) is in the closed position and staples (66)are driven out of stapling head assembly (20) into staple formingpockets (52), as shown in FIG. 2C, legs (68) of staples (66) are bent toform completed staples.

With anvil (40) as a separate component, it should be understood thatanvil (40) may be inserted and secured to a portion of tissue (2) priorto being coupled to stapling head assembly (20). By way of example only,anvil (40) may be inserted into and secured to a first tubular portionof tissue (2) while instrument (10) is inserted into and secured to asecond tubular portion of tissue (2). For instance, the first tubularportion of tissue (2) may be sutured to or about a portion of anvil(40), and the second tubular portion of tissue (2) may be sutured to orabout trocar (38).

As shown in FIG. 2A, anvil (40) is then coupled to trocar (38). Trocar(38) of the present example is shown in a distal most actuated position.Such an extended position for trocar (38) may provide a larger area towhich tissue (2) may be coupled prior to attachment of anvil (40). Inaddition, the extended position of trocar (38) may also provide foreasier attachment of anvil (40) to trocar (38). Trocar (38) furtherincludes a tapered distal tip. Such a tip may be capable of piercingthrough tissue and/or aiding the insertion of anvil (40) on to trocar(38), though the tapered distal tip is merely optional. For instance, inother versions trocar (38) may have a blunt tip. In addition, or in thealternative, trocar (38) may include a magnetic portion (not shown)which may attract anvil (40) towards trocar (38). Of course stillfurther configurations and arrangements for anvil (40) and trocar (38)will be apparent to one of ordinary skill in the art in view of theteachings herein.

When anvil (40) is coupled to trocar (38), the distance between aproximal face of the anvil (40) and a distal face of stapling headassembly (20) defines a gap distance d. Trocar (38) of the presentexample is translatable longitudinally relative to stapling headassembly (20) via an adjusting knob (98) located at a proximal end ofactuator handle assembly (70), as will be described in greater detailbelow. Accordingly, when anvil (40) is coupled to trocar (38), rotationof adjusting knob (98) enlarges or reduces gap distance d by actuatinganvil (40) relative to stapling head assembly (20). For instance, asshown sequentially in FIGS. 2A-2B, anvil (40) is shown actuatingproximally relative to actuator handle assembly (70) from an initial,open position to a closed position, thereby reducing the gap distance dand the distance between the two portions of tissue (2) to be joined.Once the gap distance d is brought within a predetermined range,stapling head assembly (20) may be fired, as shown in FIG. 2C, to stapleand sever tissue (2) between anvil (40) and stapling head assembly (20).Stapling head assembly (20) is operable to staple and sever tissue (2)by a user pivoting a trigger (74) of actuator handle assembly (70), aswill be described in greater detail below. In some other versions,stapling head assembly (20) is actuated via motor or is otherwisepowered.

As noted above, gap distance d corresponds to the distance between anvil(40) and stapling head assembly (20). When instrument (10) is insertedinto a patient, this gap distance d may not be easily viewable.Accordingly, a moveable indicator bar (110), shown in FIGS. 5-6, isprovided to be visible through an indicator window (120) positionedopposite to trigger (74). Indicator bar (110) is operable to move inresponse to rotation of adjusting knob (98) such that the position ofindicator bar (110) is representative of the gap distance d. As shown inFIG. 6, indicator window (120) further comprises a scale (130) whichindicates that the anvil gap is within a desired operating range (e.g.,a green colored region or “green zone”) and a corresponding staplecompression representation at each end of scale (130). By way of exampleonly, as shown in FIG. 6, a first staple image (132) depicts a largestaple height while a second staple image (134) depicts a small stapleheight. Accordingly, a user can view the position of the coupled anvil(40) relative to the stapling head assembly (20) via indicator bar (110)and scale (130). The user may then adjust the positioning of anvil (40)via adjusting knob (98) accordingly.

Referring back to FIGS. 2A-2C, a user sutures a portion of tissue (2)about tubular member (44) such that anvil head (48) is located within aportion of the tissue (2) to be stapled. When tissue (2) is attached toanvil (40), retaining clips (46) and a portion of tubular member (44)protrude out from tissue (2) such that the user may couple anvil (40) totrocar (38). With tissue (2) coupled to trocar (38) and/or anotherportion of stapling head assembly (20), the user attaches anvil (40) totrocar (38) and actuates anvil (40) proximally towards stapling headassembly (20) to reduce the gap distance d. Once instrument (10) iswithin the operating range, the user then staples together the ends oftissue (2), thereby forming a substantially contiguous tubular portionof tissue (2).

Anvil (40) may be further constructed in accordance with at least someof the teachings of U.S. Pat. No. 5,205,459; U.S. Pat. No. 5,271,544;U.S. Pat. No. 5,275,322; U.S. Pat. No. 5,285,945; U.S. Pat. No.5,292,053; U.S. Pat. No. 5,333,773; U.S. Pat. No. 5,350,104; U.S. Pat.No. 5,533,661, the disclosures of which are incorporated by referenceherein; and/or in accordance with other configurations as will beapparent to one of ordinary skill in the art in view of the teachingsherein.

B. Exemplary Stapling Head Assembly

Stapling head assembly (20) of the present example is coupled to adistal end of shaft assembly (60) and comprises a tubular casing (22)housing a slidable staple driver (24) and a plurality of staples (66)contained within staple pockets (32). Staples (66) and staple pockets(32) are disposed in a circular array about tubular casing (22). In thepresent example, staples (66) and staple pockets (32) are disposed in apair of concentric annular rows of staples (66) and staple pockets (32).Staple driver (24) is operable to actuate longitudinally within tubularcasing (22) in response to rotation of trigger (74) of actuator handleassembly (70). As shown in FIGS. 2A-2C, staple driver (24) comprises aflared cylindrical member having a trocar opening (26), a central recess(28), and a plurality of members (30) disposed circumferentially aboutcentral recess (28) and extending distally relative to shaft assembly(60). Each member (30) is configured to contact and engage acorresponding staple (66) of the plurality of staples (66) within staplepockets (32). Accordingly, when staple driver (24) is actuated distallyrelative to actuator handle assembly (70), each member (30) drives acorresponding staple (66) out of its staple pocket (32) through a stapleaperture (34) formed in a distal end of tubular casing (22). Becauseeach member (30) extends from staple driver (24), the plurality ofstaples (66) are driven out of stapling head assembly (20) atsubstantially the same time. When anvil (40) is in the closed position,staples (66) are driven into staple forming pockets (52) to bend legs(68) of the staples (66), thereby stapling the material located betweenanvil (40) and stapling head assembly (20). FIG. 3 depicts one merelyexemplary staple (66) driven by a member (30) into a staple formingpocket (32) of anvil (40) to bend legs (68).

Staple driver (24) further includes a cylindrical knife (36) that iscoaxial to trocar opening (26) and inset from staple pockets (32). Inthe present example, cylindrical knife (36) is disposed within centralrecess (28) to translate distally with staple driver (24). When anvil(40) is secured to trocar (38), as described above, anvil head (48)provides a surface against which cylindrical knife (36) cuts thematerial contained between anvil (40) and stapling head assembly (20).In some versions, anvil head (48) may include a recess (not shown) forcylindrical knife (36) to aid in cutting the material (e.g., byproviding a cooperative shearing edge). In addition, or in thealternative, anvil head (48) may include one or more opposingcylindrical knives (not shown) offset from cylindrical knife (36) suchthat a scissor-type cutting action may be provided. Still otherconfigurations will be apparent to one of ordinary skill in the art inview of the teachings herein. Stapling head assembly (20) is thusoperable to both staple and cut tissue (2) substantially simultaneouslyin response to actuation by actuator handle assembly (70).

Of course stapling head assembly (20) may be further constructed inaccordance with at least some of the teachings of U.S. Pat. No.5,205,459; U.S. Pat. No. 5,271,544; U.S. Pat. No. 5,275,322; U.S. Pat.No. 5,285,945; U.S. Pat. No. 5,292,053; U.S. Pat. No. 5,333,773; U.S.Pat. No. 5,350,104; U.S. Pat. No. 5,533,661, the disclosures of whichare incorporated by reference herein; and/or in accordance with otherconfigurations as will be apparent to one of ordinary skill in the artin view of the teachings herein.

As noted previously, staple driver (24) includes a trocar opening (26).Trocar opening (26) is configured to permit trocar (38) tolongitudinally slide relative to stapling head assembly (20) and/orshaft assembly (60). As shown in FIGS. 2A-2C, trocar (38) is coupled toa trocar actuator (39) such that trocar (38) can be actuatedlongitudinally via rotation of rotating knob (98), as will be describedin greater detail below in reference to actuator handle assembly (70).In the present example, trocar actuator (39) comprises an elongated,relatively stiff shaft coupled to trocar (38), though this is merelyoptional. In some versions, actuator (39) may comprise a longitudinallystiff material while permitting lateral bending such that portions ofinstrument (10) may be selectively bent or curved during use; orinstrument (10) may include a preset bent shaft assembly (60). Onemerely exemplary material is nitinol. When anvil (40) is coupled totrocar (38), trocar (38) and anvil (40) are translatable via actuator(39) to adjust the gap distance d between anvil (40) and stapling headassembly (20). Still further configurations for actuator (39) tolongitudinally actuate trocar (38) will be apparent to one of ordinaryskill in the art in view of the teachings herein.

C. Exemplary Shaft Assembly

Stapling head assembly (20) and trocar (38) are positioned at a distalend of shaft assembly (60), as shown in FIGS. 2A-2C. Shaft assembly (60)of the present example comprises an outer tubular member (62) and adriver actuator (64). Outer tubular member (62) is coupled to tubularcasing (22) of stapling head assembly (20) and to a body (72) ofactuator handle assembly (70), thereby providing a mechanical ground forthe actuating components therein. The proximal end of driver actuator(64) is coupled to a trigger actuation assembly (84) of actuator handleassembly (70), described below. The distal end of driver actuator (64)is coupled to staple driver (24) such that the rotation of trigger (74)longitudinally actuates staple driver (24). As shown in FIGS. 2A-2C,driver actuator (64) comprises a tubular member having an openlongitudinal axis such that actuator (39) coupled to trocar (38) mayactuate longitudinally within and relative to driver actuator (64). Ofcourse it should be understood that other components may be disposedwithin driver actuator (64) as will be apparent to one of ordinary skillin the art in view of the teachings herein.

Shaft assembly (60) may be further constructed in accordance with atleast some of the teachings of U.S. Pat. No. 5,205,459; U.S. Pat. No.5,271,544; U.S. Pat. No. 5,275,322; U.S. Pat. No. 5,285,945; U.S. Pat.No. 5,292,053; U.S. Pat. No. 5,333,773; U.S. Pat. No. 5,350,104; U.S.Pat. No. 5,533,661, the disclosures of which are incorporated byreference herein; and/or in accordance with other configurations as willbe apparent to one of ordinary skill in the art in view of the teachingsherein.

D. Exemplary Actuator Handle Assembly

Referring now to FIGS. 4A-5, actuator handle assembly (70) comprises abody (72), a trigger (74), a lockout feature (82), a trigger actuationassembly (84), and a trocar actuation assembly (90). Trigger (74) of thepresent example is pivotably mounted to body (72) and is coupled totrigger actuation assembly (84) such that rotation of trigger (74) froman unfired position (shown in FIG. 4A) to a fired position (shown inFIG. 4B) actuates driver actuator (64) described above. A spring (78) iscoupled to body (72) and trigger (74) to bias trigger (74) towards theunfired position. Lockout feature (82) is a pivotable member that iscoupled to body (72). In a first, locked position, lockout feature (82)is pivoted upwards and away from body (72) such that lockout feature(82) engages trigger (74) and mechanically resists actuation of trigger(74) by a user. In a second, unlocked position, such as that shown inFIGS. 1 and 4B, lockout feature (82) is pivoted downward such thattrigger (74) may be actuated by the user. Accordingly, with lockoutfeature (82) in the second position, trigger (74) can engage a triggeractuation assembly (84) to fire instrument (10).

As shown in FIGS. 4A-4B, trigger actuation assembly (84) of the presentexample comprises a slidable trigger carriage (86) engaged with aproximal end of driver actuator (64). Carriage (86) includes a set oftabs (88) on a proximal end of carriage (86) to retain and engage a pairof trigger arms (76) extending from trigger (74). Accordingly, whentrigger (74) is pivoted, carriage (86) is actuated longitudinally andtransfers the longitudinal motion to driver actuator (64). In theexample shown, carriage (86) is fixedly coupled to the proximal end ofdriver actuator (64), though this is merely optional. Indeed, in onemerely exemplary alternative, carriage (86) may simply abut driveractuator (64) while a distal spring (not shown) biases driver actuator(64) proximally relative to actuator handle assembly (70).

Trigger actuation assembly (84) may be further constructed in accordancewith at least some of the teachings of U.S. Pat. No. 5,205,459; U.S.Pat. No. 5,271,544; U.S. Pat. No. 5,275,322; U.S. Pat. No. 5,285,945;U.S. Pat. No. 5,292,053; U.S. Pat. No. 5,333,773; U.S. Pat. No.5,350,104; U.S. Pat. No. 5,533,661, the disclosures of which areincorporated by reference herein; and/or in accordance with otherconfigurations as will be apparent to one of ordinary skill in the artin view of the teachings herein.

Body (72) also houses a trocar actuation assembly (90) configured toactuate trocar (38) longitudinally in response to rotation of adjustingknob (98). As best shown in FIGS. 4A-5, trocar actuation assembly (90)of the present example comprises adjusting knob (98), a grooved shank(94), and a sleeve (92). Grooved shank (94) of the present example islocated at a distal end of trocar actuator (39), though it should beunderstood that grooved shank (94) and trocar actuator (39) mayalternatively be separate components that engage to transmitlongitudinal movement. Adjusting knob (98) is rotatably supported by theproximal end of body (72) and is operable to rotate sleeve (92) that isengaged with grooved shank (94) via an internal tab (not shown). Groovedshank (94) of the present example comprises a continuous groove (96)formed in the outer surface of grooved shank (94). Accordingly, whenadjusting knob (98) is rotated, the internal tab rides within groove(96) and grooved shank (94) is longitudinally actuated relative tosleeve (92). Since grooved shank (94) is located at the distal end oftrocar actuator (39), rotating adjusting knob (98) in a first directionadvances trocar actuator (39) distally relative to actuator handleassembly (70). Accordingly, the gap distance d between anvil (40) andstapling head assembly (20) is increased. By rotating adjusting knob(98) in the opposite direction, trocar actuator (39) is actuatedproximally relative to actuator handle assembly (70) to reduce the gapdistance d between anvil (40) and stapling head assembly (20). Thus,trocar actuation assembly (90) is operable to actuate trocar (38) inresponse to rotating adjustment knob (98). Of course otherconfigurations for trocar actuation assembly (90) will be apparent toone of ordinary skill in the art in view of the teachings herein.

Groove (96) of the present example comprises a plurality of differentportions (96A, 96B, 96C) that have a varying pitch or number of groovesper axial distance. The present groove (96) is divided into a distalportion (96A), a middle portion (96B) and a proximal portion (96C). Asshown in FIG. 5, distal portion (96A) comprises a fine pitch or a highnumber of grooves over a short axial distance of grooved shank (94) suchthat a large number of rotations of adjusting knob (98) are required totraverse the short axial distance. Middle portion (96B) comprises asection with comparably coarser pitch or fewer grooves per axialdistance such that relatively few rotations are required to traverse along axial distance. Accordingly, the gap distance d may be quicklyreduced through relatively few rotations of adjusting knob (98).Proximal portion (96C) of the present example is substantially similarto distal portion (96A) and comprises a fine pitch or a high number ofgrooves over a short axial distance of grooved shank (94) such that alarge number of rotations are required to traverse the short axialdistance. Proximal portion (96C) of the present example is positionedwithin sleeve (92) when anvil (40) is substantially near to staplinghead assembly (20) such that indicator bar (110) moves within indicatorwindow (120) along scale (130) to indicate that the anvil gap is withina desired operating range, as will be described in more detail below.Accordingly, when the tab is within proximal portion (96C) of groove(96), each rotation of adjusting knob (98) may reduce the gap distance dby a small amount to provide for fine tuning.

Trocar actuation assembly (90) may be further constructed in accordancewith at least some of the teachings of U.S. Pat. No. 5,205,459; U.S.Pat. No. 5,271,544; U.S. Pat. No. 5,275,322; U.S. Pat. No. 5,285,945;U.S. Pat. No. 5,292,053; U.S. Pat. No. 5,333,773; U.S. Pat. No.5,350,104; U.S. Pat. No. 5,533,661, the disclosures of which areincorporated by reference herein; and/or in accordance with otherconfigurations as will be apparent to one of ordinary skill in the artin view of the teachings herein.

In the example shown in FIGS. 4A-4B, a U-shaped clip (100) is attachedto an intermediate portion of trocar actuator (39) located distally ofgrooved shank (94). In the present example, an extension of trocaractuator (39) engages a slot in the housing of handle assembly (70) toprevent trocar actuator (39) from rotating about its axis when adjustingknob (98) is rotated. In some other versions, U-shaped clip (100)engages with a portion of body (72) to substantially prevent trocaractuator (39) from rotating about its axis when adjusting knob (98) isrotated. U-shaped clip (100) of the present example further includes anelongated slot (102) on each of its opposite sides for receiving anattachment member, such as a screw, bolt, pin, clip, etc., toselectively adjust the longitudinal position of elongated slot (102) ofU-shaped clip (100) relative to trocar actuator (39) for purposes ofcalibrating indicator bar (110) relative to scale (130).

As shown in FIG. 5, actuator handle assembly (70) further includes anindicator bracket (140) configured to engage and pivot an indicator(104). Indicator bracket (140) of the present example is slidablerelative to body (72) along a pair of slots formed on body (72).Indicator bracket (140) comprises a rectangular plate (144), anindicator arm (146), and an angled flange (142). Angled flange (142) isformed at the proximal end of rectangular plate (144) and includes anaperture (not shown) to slidable mount onto trocar actuator (39) and/orgrooved shank (94). A coil spring (150) is interposed between flange(142) and a boss (152) to bias flange (142) against U-shaped clip (100).Accordingly, when U-shaped clip (100) actuates distally with trocaractuator (39) and/or grooved shank (94), coil spring (150) urgesindicator bracket (140) to travel distally with U-shaped clip (100). Inaddition, U-shaped clip (100) urges indicator bracket (140) proximallyrelative to boss (152) when trocar actuator (39) and/or grooved shank(94) translate proximally, thereby compressing coil spring (150). Ofcourse, it should be understood that in some versions indicator bracket(140) may be fixedly attached to trocar actuator (39) and/or groovedshank (94).

In the present example, a portion of lockout feature (82) abuts asurface (141) of indicator bracket (140) when indicator bracket (140) isin a longitudinal position that does not correspond to when the anvilgap is within a desired operating range (e.g., a green colored region or“green zone”). When the anvil gap is within a desired operating range(e.g., a green colored region or “green zone”), indicator bracket (140)narrows to provide a pair of gaps (145) on either side of an indicatorarm (146) that permits lockout feature (82) to pivot, thereby releasingtrigger (74). Accordingly, lockout feature (82) and indicator bracket(140) can substantially prevent a user from releasing and operatingtrigger (74) until anvil (40) is in a predetermined operating range. Ofcourse it should be understood that lockout feature (82) may be omittedentirely in some versions.

This operating range may be visually communicated to the user via anindicator bar (110) of an indicator (104) shown against a scale (130),described briefly above. At the distal end of indicator bracket (140) isa distally projecting indicator arm (146) which terminates at alaterally projecting finger (148) for controlling the movement ofindicator (104). Indicator arm (146) and finger (148), best shown inFIG. 5, are configured to engage a tab (106) of indicator (104) suchthat indicator (104) is pivoted when indicator bracket (140) is actuatedlongitudinally. In the present example, indicator (104) is pivotablycoupled to body (72) at a first end of indicator (104), though this ismerely optional and other pivot points for indicator (104) will beapparent to one of ordinary skill in the art in view of the teachingsherein. An indicator bar (110) is positioned on the second end ofindicator (104) such that indicator bar (110) moves in response to theactuation of indicator bracket (140). Accordingly, as discussed above,indicator bar (110) is displayed through an indicator window (120)against a scale (130) (shown in FIG. 6) to show the relative gapdistance d between anvil (40) and stapling head assembly (20).

Of course indicator bracket (140), indicator (104), and/or actuatorhandle assembly (70) may be further constructed in accordance with atleast some of the teachings of U.S. Pat. No. 5,205,459; U.S. Pat. No.5,271,544; U.S. Pat. No. 5,275,322; U.S. Pat. No. 5,285,945; U.S. Pat.No. 5,292,053; U.S. Pat. No. 5,333,773; U.S. Pat. No. 5,350,104; U.S.Pat. No. 5,533,661, the disclosures of which are incorporated byreference herein; and/or in accordance with other configurations as willbe apparent to one of ordinary skill in the art in view of the teachingsherein.

II. Exemplary Trans-Oral Circular Anvil Introduction System

As described above, anvil (40) may be provided as a separate componentsuch that anvil (40) may be inserted and secured to a portion of tissue(2) prior to being coupled to stapling head assembly (20). For instance,it may be desirable to introduce anvil (40) trans-orally for procedureswithin a patient's gastro-intestinal tract (e.g., an esophagectomy).FIG. 7 depicts an initial stage of an anastomosis procedure to couplesevered esophagus sections (2, 4) following an esophagectomy. Anvil (40)is inserted trans-orally through the esophagus using an endoscope (6)and is positioned within a first severed section (2) of the esophagus.Instrument (10) is inserted through the stomach and positioned within asecond severed section (4) of the esophagus. Anvil (40) is then coupledto trocar (38) of instrument (10) to staple and seal severed sections(2, 4) of the esophagus in an anastomosis. Anvil (40) may also beinserted within other bodily lumens or regions of the gastro-intestinaltract to perform an anastomosis as will be apparent to one with ordinaryskill in the art in view of the teachings herein. Because improperintroduction of anvil (40) may irritate the esophagus, it may bedesirable to provide a trans-oral circular anvil introduction system tosmoothly insert anvil (40) through the bodily lumen. An anvilintroduction system may comprise dilation features to cover at least theproximal side of anvil (40) during insertion, if not the entire anvil(40) during insertion; or the system may comprise anvil graspingfeatures to insert anvil (40) upside-down such that the proximal side ofanvil (40) faces away from tissue. Various examples of such featureswill be described in greater detail below, while other examples will beapparent to one with ordinary skill in the art in view of the teachingsherein.

A. Exemplary Dilation Features

An anvil introduction system may comprise anvil dilation features thateither inflate or expand to cover the proximal side of anvil (40) duringinsertion. Such dilation features may prevent an outer perimeter edge atthe proximal side of anvil (40) from dragging along the inner wall ofthe esophagus as anvil (40) is transported through the esophagus toreach the desired anastomosis site. Various examples of such featureswill be described in greater detail below, while other examples will beapparent to one with ordinary skill in the art in view of the teachingsherein.

1. Exemplary Inflatable Feature

An exemplary trans-oral circular anvil introduction system (200) isshown in FIGS. 8-10. Anvil introduction system (200) of the presentexample comprises a dilation feature, such as inflatable bladder (210),which is expandable around anvil (240) to cover any sharp edges of anvil(240) during the introduction of anvil (240) through a naturallyoccurring bodily lumen (e.g. the esophagus). For example, anvilintroduction system (200) comprises an anvil (240), an inflatablebladder (210), and a flexible tube (222), as shown in FIG. 8. Anvil(240) is similar to anvil (40) described above. Anvil (240) comprisesstaple pockets (252) aligned on proximal surface (250) of anvil (240).Anvil (240) also comprises a proximally extending shaft (244). Shaft(244) is coupled to inflatable bladder (210). Inflatable bladder (210)comprises a flexible membrane that wraps around shaft (244) and inflatesto cover staple pockets (252) and the edge of proximal surface (250) ofanvil (240), as shown in FIG. 9B. In the inflated state, bladder (210)defines a tapered shape from anvil (240). Apertures (211) are providedin shaft (244) to allow air, saline, or other fluid to pass throughshaft (244) to inflate bladder (210). Tubular member (212) extends frombladder (210) to selectively couple bladder (210) to flexible tube(222). Shaft (244) is similar to proximal shaft (42) of anvil (40) suchthat shaft (244) is configured to couple with trocar (38) once anvil(240) is positioned for stapling.

Flexible tube (222) comprises a snap feature (220) and an inflation tube(224).

Snap feature (220) extends from the distal end of flexible tube (222).Snap feature (220) comprises a smaller diameter than tubular member(212) such that snap feature (220) slides or snaps into tubular member(212) to couple flexible tube (222) to tubular member (212), as shown inFIG. 9A. Snap feature (220) may also have a larger diameter than tubularmember (212) such that snap feature (220) slides around tubular member(212). Snap feature (220) may also be sutured to tubular member (212).Other suitable methods to couple flexible tube (222) to tubular member(212) will be apparent to one with ordinary skill in the art based onthe teachings herein. Inflation tube (224) is positioned within flexibletube (222). Inflation tube may be used to inject fluid into bladder(210) to inflate bladder (210). However, inflation tube (224) is merelyoptional and flexible tube (222) may be used to inject fluid intobladder (210). Flexible tube (222) may comprise a conventional NG(naso-gastric) tube or any other suitable structure.

As shown in FIG. 9A, snap feature (200) is inserted into tubular member(212) to couple flexible tube (222) to tubular member (212). Oncecoupled, inflation tube (224) introduces fluid into bladder (210) toinflate bladder (210), as shown in FIG. 9B. With bladder (210) inflated,bladder (210) covers staple pockets (252). Bladder (210) also extendspast anvil (240) to form an annular protrusion (214) to cover the edgeof proximal surface (250) of anvil (240). In the inflated state,flexible tube (222) is used to pull anvil (240) smoothly through anaturally occurring bodily lumen (e.g., the esophagus), as shown in FIG.10. Once anvil (240) is positioned by anvil introduction system (200),bladder (210) is deflated by passing the fluid back through inflationtube (224). Flexible tube (222) is then be removed from anvil (240), andanvil (240) is coupled to trocar (38) of circular surgical staplinginstrument (10) for operation.

2. Exemplary Expandable Mesh Feature

Another exemplary trans-oral circular anvil introduction system (300)comprising a dilation feature is shown in FIGS. 11-17B. Anvilintroduction system (300) comprises an anvil (340), a flexible tube(322), a sliding feature (360), and a dilation feature (361). Anvil(340) is similar to anvil (40) described above. Anvil (340) comprisesstaple pockets (352) aligned on proximal surface (350) of anvil (340),as shown in FIG. 15. Anvil (340) also comprises a shaft (344) extendingfrom proximal surface (350) of anvil (340). Shaft (344) is similar toproximal shaft (42) of anvil (40) such that shaft (344) is configured tocouple with trocar (38) once anvil (340) is positioned for stapling.Shaft (344) is coupled to flexible tube (322) as anvil (340) is beingmoved into a position for stapling. Shaft (344) comprises a smallerdiameter than flexible tube (322) such that shaft (344) slides intoflexible tube (322) to couple flexible tube (322) to anvil (340). Shaft(344) may also have a larger diameter than flexible tube (322) such thatshaft (344) may slide around flexible tube (322). Shaft (344) may alsobe sutured to flexible tube (322) through corresponding apertures (312,320) in shaft (344) and flexible tube (322). Other suitable methods tocouple flexible tube (322) to shaft (344) will be apparent to one withordinary skill in the art based on the teachings herein. Flexible tube(322) may comprise a conventional NG (naso-gastric) tube or any othersuitable structure.

Sliding feature (360) is coupled to flexible tube (322). Sliding feature(360) comprises a sliding collar (368), connecting members (367), and acam collar (366), as shown in FIG. 11. Sliding collar (368) wraps aroundflexible tube (322) such that sliding collar (368) slides proximallyand/or distally along flexible tube (322). A cam collar (366) ispositioned distal to sliding collar (368) and cam collar (366) alsowraps around flexible tube (322) such that cam collar (366) slidesproximally and/or distally along flexible tube (322). Cam collar (366)defines a tapered configuration. One or more connecting members (367)extend between sliding collar (368) and cam collar (366) to connectsliding collar (368) to cam collar (366).

Dilation feature (361) is also coupled to flexible tube (322), as shownin FIGS. 13-14. Dilation feature (361) comprises expanding members (362)and a washer (363). Washer (363) wraps around flexible tube (322) suchthat washer (363) is positioned between cam collar (366) and slidingcollar (368). Washer (363) is fixed relative to flexible tube (322) suchthat sliding feature (360) also slides relative to washer (363). Aplurality of expanding members (362) extend distally from washer (363)to anvil (340). Expanding members (362) are positioned to extend fromunderneath sliding collar (368) and over cam collar (366), as shown inFIG. 11. A mesh (364) is applied to dilation feature (361) to coverexpanding members (362). Mesh (364) is configured to taper from anvil(340) to washer (363). Mesh (364) expands and contracts with expandingmembers (362). In the present example, mesh (364) extends up to thebottom of the head of anvil (340). In some other versions, mesh (364)fully encompasses the head of anvil (340). In addition or in thealternative, mesh (364) may fully encompass the shaft of anvil (340).

As shown in FIGS. 15-16, flexible tube (322) is coupled to anvil (340)via shaft (344), with dilation feature (361) in a collapsed state.Expanding members (362) and/or mesh (364) may be resiliently biased toassume the collapsed configuration of FIGS. 15-16. In the collapsedstate, sliding feature (360) is in a distal position such that camcollar (366) is distal to washer (363). A user grasps sliding collar(368) to translate sliding feature (360) to a proximal position, asshown in FIGS. 13-14. A conventional grasper or any other device may beused to translate sliding collar (368). As sliding collar (368)translates proximally, cam collar (366) also translates proximally toengage washer (363). The tapered configuration of cam collar (366)underneath expanding members (362) acts as a cam, pushing expandingmembers (362) outwardly to an expanded state. In the expanded state,expanding members (362) contact the edge of proximal surface (350) ofanvil (340). Mesh (364) also expands with expanding members (362). Inthe expanded state, dilation feature (361) covers the edge and staplepockets (352) of anvil (340). With proximal surface (350) of anvil (340)covered by dilation feature (361), anvil (240) is introducedtrans-orally by pulling flexible tube (322) of anvil introduction system(300) through the esophagus, as shown in FIG. 17A. When dilation feature(362) is in the expanded position, dilation feature (362) prevents theedge of anvil (340) from dragging along the inner wall of the esophagus.Once anvil (340) is in a desired position within the esophagus, suture(380) connecting flexible tube (322) and anvil shaft (344) is cut.Sliding collar (368) is then advanced distally to allow dilation feature(361) to collapse. As shown in FIG. 17B, flexible tube (322) is thenpulled to remove flexible tube (322), sliding feature (360), anddilation feature (361) from anvil (340). Anvil (340) is then coupled totrocar (38) of circular surgical stapling instrument (10) for operation.

B. Exemplary Anvil Grasping Features

An anvil (40) may comprise an anvil grasping features to facilitatepulling anvil (40) upside-down through the esophagus such that theproximal side of anvil (40) faces away from tissue. This may enable atapered or curved upper surface of anvil (40) to engage tissue as anvil(40) is pulled through the esophagus. A flexible or rigid anvil graspingfeature may be used. Various examples of such features will be describedin greater detail below, while other examples will be apparent to onewith ordinary skill in the art in view of the teachings herein.

1. Exemplary Flexible Grasping Feature

FIGS. 18-19C show an exemplary anvil assembly (400) comprising an anvilgrasping feature (448). Grasping feature (448) is used to grasp anvil(440) at an orientation with top surface (442) leading through anaturally occurring bodily lumen (e.g. the esophagus). Anvil assembly(400) comprises an anvil (440), an anvil grasping feature (448), and ananvil shaft (444), as shown in FIG. 18. Anvil (440) is similar to anvil(40) described above. Anvil (440) comprises staple pockets (452) onlower surface (450) of anvil (440). Shaft (444) extends from lowersurface (450) of anvil (440). Shaft (444) is coupleable to trocar (38).Anvil (440) defines a tapered configuration such that top surface (442)comprises a smaller diameter than lower surface (450). Grasping feature(448) extends from top surface (442) of anvil (440). Grasping feature(448) may be flexible. As shown in FIG. 18, grasping feature (448) isconfigured as a rounded tab. Grasping feature (448) may also beconfigured as a long, round cylindrical tab, or a flat fin shaped tab.Other suitable grasping configurations will be apparent to one withordinary skill in the art in view of the teachings herein.

In an exemplary use, as shown in FIGS. 19A-19C, anvil (440) isintroduced by leading top surface (442) trans-orally through theesophagus. The tapered configuration defined by anvil (440) provides asmooth transit for anvil (440) through the esophagus. A suture (450) iscoupled around shaft (444) of anvil (440). A conventional surgicalgrasper (460) is used to grab grasping feature (448) with grasping endeffector jaws (462), as shown in FIG. 19A. Grasper (460) is then pulledthrough the esophagus to trans-orally introduce anvil (440) to theintended anastomosis site. Once anvil (440) is close to a desiredpositioned within the esophagus, grasper (460) releases grasping feature(448). As shown in FIG. 19B, grasper (460) then grabs suture (450) topull anvil shaft (444) to thereby flip anvil (440) to align lowersurface (450) with the desired tissue (2) to be stapled. After anvil(440) is flipped, grasper (460) continues to pull anvil (440) intoposition, as shown in FIG. 19C. Suture (350) is then cut and grasper(460) is removed. Anvil (440) is then coupled to trocar (38) of circularsurgical stapling instrument (10) for operation.

2. Exemplary Rigid Grasping Feature

FIGS. 20-21B show another exemplary anvil assembly (700) comprising ananvil grasping feature (748). Anvil assembly (700) comprises an anvil(740) and an anvil grasping feature (748), as shown in FIG. 20. Anvil(740) is similar to anvil (40) described above. Anvil (740) comprisesstaple pockets (752) on lower surface (750) of anvil (740). A shaft(746) extends from top surface (742) of anvil (740) to connect anvilgrasping feature (748) to anvil (740). Anvil grasping feature (748)comprises a convex shaped top. An opening (744) is formed on lowersurface (750) of anvil (740) to receive trocar (738), as shown in FIG.21A. Opening (744) comprises an inwardly extending annular protrusion(743).

Trocar (738) is similar to trocar (38). Trocar (738) comprises a pointeddistal end (730), a cam portion (732), a shaft (733), and expandingmembers (736), as shown in FIG. 21A. The distal portion of shaft (733)is angled to form cam portion (732). Pointed distal end (730) ispositioned distal to cam portion (732). Shaft (733) extends throughexpanding members (736). Expanding members (736) comprise inwardlyextending recesses (734) that correspond to protrusion (743).

In an exemplary use, anvil (740) is introduced by leading top surface(742) through a naturally occurring bodily lumen (e.g. the esophagus). Agrasper is used to grab grasping feature (748) with jaws to pull anvil(740) trans-orally through the esophagus. Anvil (740) is flipped toalign lower surface (750) with tissue (2) to be stapled. Once anvil(740) is positioned within the esophagus, anvil (740) is coupled totrocar (738) for operation. In particular, trocar (738) is inserted intoopening (744) of anvil (740) until recesses (734) align with protrusion(743), as shown in FIG. 21A. Shaft (733) is pulled proximally to slideshaft (733) through expanding members (736). As shaft (733) translatesproximally, cam portion (732) pushes expanding members (736) outwardly,as shown in FIG. 21B. This causes recesses (734) to engage protrusion(743). The longitudinal position of shaft (733) relative to expandingmembers (736) is secured in order to cause recesses (734) of trocar(738) to lock anvil (740) to trocar (738) during operation of circularsurgical stapling instrument (10). After operation of instrument (10),shaft (733) may be translated distally to allow expanding members (736)to bend inwardly. This removes recesses (734) from protrusion (743) tounlock anvil (740) from trocar (738). Instrument (10) and anvil (740)may then be removed separately from the anastomosis site. Alternatively,instrument (10) may be removed from the anastomosis site with anvil(740) still coupled to trocar (738).

C. Exemplary Anvil Securing Feature

An anvil securing feature (848) may be applied to the various anvils,including those described above, to hold anvil (840) in place relativeto tissue while coupling anvil (840) to a trocar (38). An exemplaryanvil assembly (800) comprising an anvil securing feature (848) is shownin FIGS. 22A-22B. Anvil assembly (800) comprises an anvil (840) and ananvil securing feature (820). Anvil (840) is similar to anvil (40)described above. Anvil (840) comprises staple pockets (852) on lowersurface (850) of anvil (840). A shaft (844) extends from lower surface(850) of anvil (840). Anvil securing feature (848) is fixedly coupled toshaft (844). Anvil grasping feature (848) comprises a collar (822) and aflange (820) extending from collar (822), as shown in FIG. 22A. Collar(822) is configured to wrap around shaft (844) to couple anvil securingfeature (848) to anvil (840). An opening (824) is formed in flange (820)such that a suture may pass through opening (824). Alternatively, flange(820) may be formed of a compliant material to enable needle (832) topierce flange (820) at any desired location on flange (820).

Once anvil (840) is positioned within through the esophagus using any ofthe features described above, anvil securing feature (848) allows forretention of anvil (840) relative to tissue after a grasper is removedfrom anvil (840). As shown in FIGS. 22A-22B, tissue (2) is sutured in apurse-string configuration. Suture (830) then passes through opening(824) of anvil securing feature (848) by needle (832). A loop is formedthrough opening (824) around flange (820) with suture (830). As suture(830) is drawn around tissue (2) and flange (820), anvil (840) is heldin position by suture (830). With anvil (840) secured to tissue (2),anvil (840) is held in place when anvil (840) is coupled to a trocar(38). Other suitable suturing methods to retain anvil (840) will beapparent to one with ordinary skill in the art in view of the teachingsherein.

III. Miscellaneous

It should be understood that any one or more of the teachings,expressions, embodiments, examples, etc. described herein may becombined with any one or more of the other teachings, expressions,embodiments, examples, etc. that are described herein. Theabove-described teachings, expressions, embodiments, examples, etc.should therefore not be viewed in isolation relative to each other.Various suitable ways in which the teachings herein may be combined willbe readily apparent to those of ordinary skill in the art in view of theteachings herein. Such modifications and variations are intended to beincluded within the scope of the claims.

It should be appreciated that any patent, publication, or otherdisclosure material, in whole or in part, that is said to beincorporated by reference herein is incorporated herein only to theextent that the incorporated material does not conflict with existingdefinitions, statements, or other disclosure material set forth in thisdisclosure. As such, and to the extent necessary, the disclosure asexplicitly set forth herein supersedes any conflicting materialincorporated herein by reference. Any material, or portion thereof, thatis said to be incorporated by reference herein, but which conflicts withexisting definitions, statements, or other disclosure material set forthherein will only be incorporated to the extent that no conflict arisesbetween that incorporated material and the existing disclosure material.

Versions of the devices described above may have application inconventional medical treatments and procedures conducted by a medicalprofessional, as well as application in robotic-assisted medicaltreatments and procedures. By way of example only, various teachingsherein may be readily incorporated into a robotic surgical system suchas the DAVINCI™ system by Intuitive Surgical, Inc., of Sunnyvale, Calif.Similarly, those of ordinary skill in the art will recognize thatvarious teachings herein may be readily combined with various teachingsof U.S. Pat. No. 6,783,524, entitled “Robotic Surgical Tool withUltrasound Cauterizing and Cutting Instrument,” published Aug. 31, 2004,the disclosure of which is incorporated by reference herein.

Versions described above may be designed to be disposed of after asingle use, or they can be designed to be used multiple times. Versionsmay, in either or both cases, be reconditioned for reuse after at leastone use. Reconditioning may include any combination of the steps ofdisassembly of the device, followed by cleaning or replacement ofparticular pieces, and subsequent reassembly. In particular, someversions of the device may be disassembled, and any number of theparticular pieces or parts of the device may be selectively replaced orremoved in any combination. Upon cleaning and/or replacement ofparticular parts, some versions of the device may be reassembled forsubsequent use either at a reconditioning facility, or by a userimmediately prior to a procedure. Those skilled in the art willappreciate that reconditioning of a device may utilize a variety oftechniques for disassembly, cleaning/replacement, and reassembly. Use ofsuch techniques, and the resulting reconditioned device, are all withinthe scope of the present application.

By way of example only, versions described herein may be sterilizedbefore and/or after a procedure. In one sterilization technique, thedevice is placed in a closed and sealed container, such as a plastic orTYVEK bag. The container and device may then be placed in a field ofradiation that can penetrate the container, such as gamma radiation,x-rays, or high-energy electrons. The radiation may kill bacteria on thedevice and in the container. The sterilized device may then be stored inthe sterile container for later use. A device may also be sterilizedusing any other technique known in the art, including but not limited tobeta or gamma radiation, ethylene oxide, or steam.

Having shown and described various embodiments of the present invention,further adaptations of the methods and systems described herein may beaccomplished by appropriate modifications by one of ordinary skill inthe art without departing from the scope of the present invention.Several of such potential modifications have been mentioned, and otherswill be apparent to those skilled in the art. For instance, theexamples, embodiments, geometrics, materials, dimensions, ratios, steps,and the like discussed above are illustrative and are not required.Accordingly, the scope of the present invention should be considered interms of the following claims and is understood not to be limited to thedetails of structure and operation shown and described in thespecification and drawings.

1-20. (canceled)
 21. An apparatus for stapling tissue, the apparatuscomprising: (a) an anvil, wherein the anvil comprises: (i) a distalsurface, (ii) a proximal surface, (iii) a plurality of staple pockets,wherein the plurality of staple pockets are formed on the proximalsurface of the anvil, and (iv) a shaft comprising a distal end and anopen proximal end, wherein the shaft extends from the proximal surface;wherein the anvil is configured to be inserted through a bodily lumen;and (b) an anvil introduction system coupled with the anvil, wherein theanvil introduction system comprises: (i) a flexible tube configuredselectively couple with the shaft at the open proximal end, and (ii) adilation feature configured to transition between a collapsed positionand an expanded position, wherein the dilation feature is configured tocover the staple pockets of the anvil in the expanded position, whereinthe dilation feature is configured to be in the expanded position whenthe anvil is inserted through the bodily lumen.
 22. The apparatus ofclaim 21, wherein the flexible tube is configured to transition thedilation feature between the collapsed position and the expandedposition.
 23. The apparatus of claim 22, wherein the dilation featurecomprises an inflatable bladder.
 24. The apparatus of claim 23, whereina portion of the inflatable bladder is fixed to the shaft such that theinflatable bladder surrounds a portion of the hollow shaft.
 25. Theapparatus of claim 24, wherein the shaft is hollow and defines anaperture in fluid communication with an interior of the inflatablebladder.
 26. The apparatus of claim 25, wherein the flexible tube isconfigured to be in fluid communication with an interior of the shaftwhen the flexible tube is coupled with the open proximal end of theshaft.
 27. The apparatus of claim 26, wherein the flexible tube isconfigured to inject fluid into the inflatable bladder via the interiorof the shaft and the aperture to transition the dilation feature betweena collapsed position and the expanded position.
 28. The apparatus ofclaim 21, wherein the flexible tube is configured to selectively couplewith the shaft via a snap fit feature.
 29. The apparatus of claim 21,wherein the anvil introduction system further comprises a slidingfeature slidably coupled to the flexible tube, wherein the slidingfeature is configured to drive the dilation feature between thecollapsed position and the expanded position.
 30. The apparatus of claim29, wherein the sliding feature further comprises a camming member. 31.The apparatus of claim 30, wherein the dilation feature comprises anexpandable member extending from the flexible tube toward to proximalsurface of the anvil, wherein the camming member is configured totransition from a first position to a second position relative to theflexible tube to drive the expandable member from the collapsed positionto the expanded position.
 32. The apparatus of claim 31, wherein theexpandable member is coupled to the flexible tube via a washer.
 33. Theapparatus of claim 31, wherein the expandable member further comprises amesh member encompassing the proximal surface of the anvil.
 34. Theapparatus of claim 21, wherein the flexible tube defines a firstaperture, wherein the shaft defines a second aperture, wherein the firstaperture and the second aperture are configured to align when theflexible tube and the hollow shaft are selectively coupled.
 35. Theapparatus of claim 34, wherein the flexible tube and the shaft areconfigured to selectively couple via a suture within the first apertureand the second aperture.
 36. An apparatus for stapling tissue, theapparatus comprising: (a) an anvil, wherein the anvil comprises: (i) adistal end, (ii) a proximal end, (iii) a distal surface extending fromthe distal end, (iv) a proximal surface, (v) a plurality of staplepockets, wherein the plurality of staple pockets are formed on theproximal surface of the anvil, and (vi) a shaft extending from theproximal surface and terminating at the proximal end; wherein the anvilis configured to be inserted through a bodily lumen; and (b) an anvilintroduction system coupled with the anvil, wherein the anvilintroduction system comprises a dilation feature configured totransition between a collapsed position and an expanded position,wherein the dilation feature is configured to cover the staple pocketsof the anvil in the expanded position, wherein the dilation featureterminates proximal to the distal end of the anvil, wherein the dilationfeature is configured to be in the expanded position when the anvil isinserted through the bodily lumen.
 37. The apparatus of claim 36,wherein the dilation feature comprises an inflatable bladder.
 38. Theapparatus of claim 37, wherein the inflatable bladder is fixed with aportion of the shaft.
 39. The apparatus of 36, wherein the dilationfeature comprises a camming member and an expanding member, whereintranslation of the camming member is configured to drive the expandingmember.
 40. An apparatus for stapling tissue, the apparatus comprising:(a) an anvil, wherein the anvil comprises: (i) a distal surface, (ii) aproximal surface, and (iii) a plurality of staple pockets, wherein theplurality of staple pockets are formed on the proximal surface of theanvil, and wherein the anvil is configured to be inserted through abodily lumen; and (b) an anvil introduction system coupled with theanvil, wherein the anvil introduction system comprises a dilationfeature configured to transition between a collapsed position and anexpanded position, wherein the dilation feature is configured to coverthe staple pockets of the anvil in the expanded position withoutcovering the entire anvil, wherein the dilation feature terminatesproximal to the distal surface, wherein the dilation feature isconfigured to be in the expanded position when the anvil is insertedthrough the bodily lumen.